Health · Healthcare & Policy · 3 hrs ago
FDA scientists opposed plan to ease access to unapproved peptides
Health Secretary Robert F. Kennedy Jr’s department issued a policy to ease access to certain peptides in the United States.
The injectable products are promoted by wellness businesses for muscle building, injury recovery and energy, but the FDA has not approved them as safe and effective.
The policy tells the FDA not to take action against specialty pharmacies that sell about six of these peptides, including BPC-157.
Most FDA scientific staff opposed the plan, warning it could weaken the agency’s role in keeping unproven drugs off the market.
The department first wanted a formal rule treating the substances as safe for use in customized medicines, but changed course after FDA officials raised safety concerns.
The revised approach includes safeguards, such as requiring pharmacies to use ingredients from FDA-registered factories.
The policy addresses concerns that Americans are buying peptides through unregulated online sellers, while oversight of compounded drugs has usually been led by the FDA.
Most FDA scientific staff members opposed an effort to make certain unapproved peptide drugs easier to access, according to six people familiar with the policy’s development.
The policy directs the FDA not to act against specialty pharmacies that sell a half-dozen wellness peptides.
The peptides have not been approved by the FDA as safe and effective.
HHS officials initially sought an official regulation, but changed course after FDA officials raised safety concerns.
FDA staff provided technical assistance on the final plan, including safeguards for peptide ingredients.
- Who
- Most FDA scientific staff members opposed the effort. HHS officials led its development.
- What
- The policy directs the FDA not to act against specialty pharmacies selling a half-dozen wellness peptides.
- When
- The document was posted online Wednesday, October 28, 2026.
- Where
- The policy concerns access to peptide drugs in the United States.
- Why
- Health Secretary Robert F. Kennedy Jr. has argued that U.S. pharmacies should be allowed to sell peptides because Americans are turning to products from the gray market.
FDA scientific staff
HHS officials
Policy approach
FDA scientific staff
FDA staff warned against a regulation deeming the peptides safe and said they had major safety concerns.
HHS officials
HHS officials initially sought an official regulation, then pursued a plan directing the FDA not to enforce its rules against pharmacies that compound the substances.
Public health and access
FDA scientific staff
FDA staff warned the effort could undermine the agency’s mission of keeping unproven health products off the U.S. market.
HHS officials
Kennedy has said U.S. compounding pharmacies should be allowed to sell peptides because Americans are turning to gray-market products imported from China and other countries.
HHS officials wanted the FDA to draft a regulation adding BPC-157 and other peptides to a list of substances considered safe for use by compounding pharmacies.
FDA officials raised safety concerns, and HHS officials shifted to a plan directing the agency not to enforce its rules against pharmacies that compound the peptides.
HHS posted the document online.
- Peptides covered
- A half-dozen wellness peptides, including BPC-157, TB-500 and KPV
- Policy direction
- FDA not to take action against specialty pharmacies selling the peptides
- Development sources
- Six people familiar with the policy
- Safety safeguard
- Peptide ingredients from FDA-registered factories
- Policy lead
- HHS led the effort, with FDA staff providing technical assistance
3 sources
What people are saying
big fan
gray market